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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01380587
Other study ID # XCL1 in ALL
Secondary ID
Status Completed
Phase N/A
First received June 22, 2011
Last updated August 26, 2013
Start date November 2010
Est. completion date September 2012

Study information

Verified date August 2013
Source Hospital Universitario Dr. Jose E. Gonzalez
Contact n/a
Is FDA regulated No
Health authority Mexico: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia.


Description:

Each year approximately 256,000 children and adults around the world develop a form of leukemia, and 209,000 died from it. Recently, some studies have evaluated the relationship between the concentration of some cytokines and prognosis of acute lymphoblastic leukemia. XCL1 is a lymphotactin that belongs to a cytokine subfamily called C or γ with only one cysteine in the N-terminal residue. It has been found with significant expression of receptor mRNA XCL1 (XCR1) in T and B lymphocytes and related to hematological neoplasms. For these reasons, XCL1 could be a efficient marker of prognosis in patients with acute lymphoblastic leukemia.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 1 Year and older
Eligibility Inclusion Criteria:

Patients with newly diagnosed acute lymphoblastic leukemia .

Exclusion Criteria:

- Patients with prior treatment with chemotherapeutic agents.

- Patients treated with immunosuppressants.

- Patients under 12 months old.

- Patients with a diagnosis or history of autoimmune diseases.

- Patients with a diagnosis or history of immunosuppressive diseases.

- Patients who do not agree to sign a Letter of Informed Consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Mexico Hospital Universitario Dr. Jose E. Gonzalez UANL Monterrey Nuevo Leon

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

Bazan JF, Bacon KB, Hardiman G, Wang W, Soo K, Rossi D, Greaves DR, Zlotnik A, Schall TJ. A new class of membrane-bound chemokine with a CX3C motif. Nature. 1997 Feb 13;385(6617):640-4. — View Citation

Huang H, Li F, Cairns CM, Gordon JR, Xiang J. Neutrophils and B cells express XCR1 receptor and chemotactically respond to lymphotactin. Biochem Biophys Res Commun. 2001 Feb 23;281(2):378-82. — View Citation

Oppenheim JJ, Zachariae CO, Mukaida N, Matsushima K. Properties of the novel proinflammatory supergene "intercrine" cytokine family. Annu Rev Immunol. 1991;9:617-48. Review. — View Citation

Rollins BJ. Chemokines. Blood. 1997 Aug 1;90(3):909-28. Review. — View Citation

Stievano L, Tosello V, Marcato N, Rosato A, Sebelin A, Chieco-Bianchi L, Amadori A. CD8+ alpha beta+ T cells that lack surface CD5 antigen expression are a major lymphotactin (XCL1) source in peripheral blood lymphocytes. J Immunol. 2003 Nov 1;171(9):4528-38. — View Citation

Taub DD, Oppenheim JJ. Chemokines, inflammation and the immune system. Ther Immunol. 1994 Aug;1(4):229-46. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with poor prognosis and high levels of XCL1 Number of patients with high levels of XCL1, expression of its receptor and other cytokines. 3 months No
Primary Number of patients with poor prognosis and high levels of cytokines Measurements obtained will be evaluated to assess the prognosis of patients and made correlations with the concentration of IL-1ß, IL-2 and XCL1 as well as the relationship XCR1 XCL1 and in leukemic cells. 3 months No
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